Medical instrument with integral navigation control features

ABSTRACT

Variations of integral navigation controls may be used in conjunction with a medical instrument to provide navigation functions for an image guided surgery (IGS) system that is in communication with the integral navigation controls. In some variations, a medical instrument with integrated navigation wheels allows movement of a cursor of the IGS system along the x and y axis by scrolling the wheel, or allows selection, zooming, or other controls by combined clicking and/or scrolling of wheels, and may be sterilized or discarded along with the device. In some other variations, a control overlay may be temporarily attached to the medical instrument to provide additional controls, such as buttons or a pointing stick, and then removed and sterilized or discarded after a procedure. In each variation, inputs may be communicated via wire or wirelessly to an IGS system to provide navigation of images during a surgical procedure.

PRIORITY

This application is a continuation-in-part of U.S. non-provisionalpatent application Ser. No. 16/021,335, filed Jun. 28, 2018, entitled“Medical Instrument with Integral Navigation Control,” which itselfclaims the benefit of U.S. provisional patent application 62/610,993,filed Dec. 28, 2017, the disclosures of each of which are herebyincorporated by reference in their entirety.

BACKGROUND

In some instances, it may be desirable to dilate an anatomicalpassageway in a patient. This may include dilation of ostia of paranasalsinuses (e.g., to treat sinusitis), dilation of the larynx, dilation ofthe Eustachian tube, dilation of other passageways within the ear, nose,or throat, etc. One method of dilating anatomical passageways includesusing a guide wire and catheter to position an inflatable balloon withinthe anatomical passageway, then inflating the balloon with a fluid(e.g., saline) to dilate the anatomical passageway. For instance, theexpandable balloon may be positioned within an ostium at a paranasalsinus and then be inflated, to thereby dilate the ostium by remodelingthe bone adjacent to the ostium, without requiring incision of themucosa or removal of any bone. The dilated ostium may then allow forimproved drainage from and ventilation of the affected paranasal sinus.A system that may be used to perform such procedures may be provided inaccordance with the teachings of U.S. Pub. No. 2011/0004057, entitled“Systems and Methods for Transnasal Dilation of Passageways in the Ear,Nose or Throat,” published Jan. 6, 2011, now abandoned, the disclosureof which is incorporated by reference herein. An example of such asystem is the Relieva® Spin Balloon Sinuplasty™ System by Acclarent,Inc. of Irvine, Calif.

Image-guided surgery (IGS) is a technique where a computer is used toobtain a real-time correlation of the location of an instrument that hasbeen inserted into a patient's body to a set of preoperatively obtainedimages (e.g., a CT or MRI scan, 3-D map, etc.), such that the computersystem may superimpose the current location of the instrument on thepreoperatively obtained images. In some IGS procedures, a digitaltomographic scan (e.g., CT or MM, 3-D map, etc.) of the operative fieldis obtained prior to surgery. A specially programmed computer is thenused to convert the digital tomographic scan data into a digital map.During surgery, special instruments having sensors (e.g.,electromagnetic coils that emit electromagnetic fields and/or areresponsive to externally generated electromagnetic fields) mountedthereon are used to perform the procedure while the sensors send data tothe computer indicating the current position of each surgicalinstrument. The computer correlates the data it receives from theinstrument-mounted sensors with the digital map that was created fromthe preoperative tomographic scan. The tomographic scan images aredisplayed on a video monitor along with an indicator (e.g., crosshairsor an illuminated dot, etc.) showing the real-time position of eachsurgical instrument relative to the anatomical structures shown in thescan images. In this manner, the surgeon is able to know the preciseposition of each sensor-equipped instrument by viewing the video monitoreven if the surgeon is unable to directly visualize the instrumentitself at its current location within the body.

An example of an electromagnetic IGS systems that may be used in ENT andsinus surgery is the CARTO® 3 System by Biosense-Webster, Inc., ofIrvine, Calif. When applied to functional endoscopic sinus surgery(FESS), balloon sinuplasty, and/or other ENT procedures, the use of IGSsystems allows the surgeon to achieve more precise movement andpositioning of the surgical instruments than can be achieved by viewingthrough an endoscope alone. As a result, IGS systems may be particularlyuseful during performance of FESS, balloon sinuplasty, and/or other ENTprocedures where anatomical landmarks are not present or are difficultto visualize endoscopically.

Navigation of the three-dimensional views of the areas surrounding theoperative field (e.g., rotating or moving a viewpoint withinthree-dimensional space) may be accomplished via interaction with aninterface device, such as a keyboard or mouse, of an IGS system. Thesetypes of interface devices might not be intended for use in a sterileenvironment, and therefore may not located within reach of a clinicianthat is performing a medical procedure with the assistance of an IGSsystem. As a result, clinicians may need to relay navigationinstructions to an assistant in another room or area, who will then usethe interface device to provide the three-dimensional views that theclinician desires. This process can be time consuming and error prone.

While several systems and methods have been made and used in ENTprocedures, it is believed that no one prior to the inventors has madeor used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1A depicts a perspective view of an exemplary dilation instrumentassembly, with a guidewire in a proximal position, and with a dilationcatheter in a proximal position;

FIG. 1B depicts a perspective view of the dilation instrument assemblyof FIG. 1A, with the guidewire in a distal position, and with thedilation catheter in the proximal position;

FIG. 1C depicts a perspective view of the dilation instrument assemblyof FIG. 1A, with the guidewire in a distal position, with the dilationcatheter in a distal position, and with a dilator of the dilationcatheter in a non-dilated state;

FIG. 1D depicts a perspective view of the dilation instrument assemblyof FIG. 1A, with the guidewire in a distal position, with the dilationcatheter in the distal position, and with a dilator of the dilationcatheter in a dilated state;

FIG. 2 depicts a schematic view of an exemplary sinus surgery navigationsystem being used on a patient seated in an exemplary medical procedurechair;

FIG. 3 depicts a perspective view of a distal portion of an exemplarydilation instrument with integral controls for IGS navigation;

FIG. 4 depicts a perspective view of a navigation wheel used as part ofthe integral controls of FIG. 3;

FIG. 5 depicts a perspective view of a shaft used as part of theintegral controls of FIG. 3;

FIG. 6 depicts a perspective view of the navigation wheel of FIG. 4, theshaft of FIG. 5, and a conductive switch that form the integral controlsof FIG. 3;

FIG. 7 depicts a perspective view of a control overlay that may be usedwith the dilation instrument assembly of FIG. 1A to provide integralcontrols for IGS navigation;

FIG. 8 depicts another perspective view of the control overlay of FIG.7;

FIG. 9 depicts another perspective view of the control overlay of FIG.7;

FIG. 10 depicts a perspective view of a handle body of the dilationinstrument assembly of FIG. 1A;

FIG. 11 depicts a perspective view of the control overlay of FIG. 7coupled with the handle body of FIG. 10;

FIG. 12A depicts a perspective view of an exemplary control clip usablewith a surgical instrument such as that shown in FIGS. 1A-1D;

FIG. 12B depicts a perspective view of a surgical instrument dilationcatheter slider which may receive the control clip of FIG. 12A;

FIG. 13 depicts a perspective view of the control clip of FIG. 12Asecured to the dilation catheter slider of FIG. 12B;

FIG. 14 depicts a perspective view of an exemplary suction instrumentassembly;

FIG. 15 depicts a schematic diagram of an exemplary proximity sensor;

FIG. 16 depicts a perspective view of a proximal portion of an exemplarysuction instrument with an integrated proximity sensor;

FIG. 17 depicts a perspective view of a proximal portion of anotherexemplary suction instrument with a set of integrated proximity sensors;

FIG. 18 depicts a perspective view of another exemplary suctioninstrument with a set of integrated controls;

FIG. 19 depicts a perspective view of an exemplary surgical debridinginstrument with a set of integrated controls;

FIG. 20 depicts a schematic diagram of an exemplary integration modulethat a surgical instrument may be configured with to provide controlduring IGS navigation; and

FIG. 21 depicts a set of steps that may be performed by a configureddevice to detect, identify, and react to inputs from one or moreproximity sensors.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. Exemplary Dilation Catheter System

FIGS. 1A-1D show an exemplary dilation instrument assembly (10) that maybe used to dilate the ostium of a paranasal sinus; to dilate some otherpassageway associated with drainage of a paranasal sinus; to dilate aEustachian tube; or to dilate some other anatomical passageway (e.g.,within the ear, nose, or throat, etc.). Dilation instrument assembly(10) of this example comprises a guidewire power source (12), aninflation source (14), an irrigation fluid source (16), and a dilationinstrument (20). In some versions, guidewire power source (12) comprisesa source of light. In some other versions, guidewire power source (12)is part of an IGS system as described below. Inflation source (14) maycomprise a source of saline or any other suitable source of fluid.Irrigation fluid source (16) may comprise a source of saline or anyother suitable source of fluid. Again, though, any other suitable sourceof fluid may be used. It should also be understood that irrigation fluidsource (16) may be omitted in some versions.

Dilation instrument (20) of the present example comprise a handle body(22) with a guidewire slider (24), a guidewire spinner (26), and adilation catheter slider (28). Handle body (22) is sized and configuredto be gripped by a single hand of a human operator. Sliders (24, 28) andspinner (26) are also positioned and configured to be manipulated by thesame hand that grasps handle body (22).

A guide catheter (60) extends distally from handle body (22). Guidecatheter (60) includes an open distal end (62) and a bend (64) formedproximal to open distal end (62). Dilation instrument (20) is configuredto removably receive several different kinds of guide catheters (60),each guide catheter (60) having a different angle formed by bend (64).Guide catheter (60) of the present example is formed of a rigid material(e.g., rigid metal and/or rigid plastic, etc.), such that guide catheter(60) maintains a consistent configuration of bend (64) during use ofdilation instrument (20). In some versions, dilation instrument (20), isfurther configured to enable rotation of guide catheter (60), relativeto handle body (22), about the longitudinal axis of the straightproximal portion of guide catheter (60), thereby further promotingaccess to various anatomical structures.

A guidewire (30) is coaxially disposed in guide catheter (60). Guidewireslider (24) is secured to guidewire (30). Translation of guidewireslider (24) relative to handle body (22) from a proximal position (FIG.1A) to a distal position (FIG. 1B) causes corresponding translation ofguidewire (30) relative to handle body (22) from a proximal position(FIG. 1A) to a distal position (FIG. 1B). When guidewire (30) is in adistal position, a distal portion of guidewire (30) protrudes distallyfrom open distal end (62) of guide catheter (60). Guidewire spinner (26)is operable to rotate guidewire (30) about the longitudinal axis ofguidewire (30). Guidewire spinner (26) is coupled with guidewire slider(24) such that guidewire spinner (26) translates longitudinally withguidewire slider (24). By way of example only, guidewire (30) may beconfigured in accordance with at least some of the teachings of U.S.Pat. No. 9,155,492, the disclosure of which is incorporated by referenceherein. Other features and operabilities that may be incorporated intoguidewire (30) will be apparent to those of ordinary skill in the art inview of the teachings herein.

A dilation catheter (40) is coaxially disposed in guide catheter (60).Dilation catheter slider (28) is secured to dilation catheter (40).Translation of dilation catheter slider (28) relative to handle body(22) from a proximal position (FIG. 1B) to a distal position (FIG. 1C)causes corresponding translation of dilation catheter (40) relative tohandle body (22) from a proximal position (FIG. 1B) to a distal position(FIG. 1C). When dilation catheter (40) is in a distal position, a distalportion of dilation catheter (40) protrudes distally from open distalend (62) of guide catheter (60). Dilation catheter (40) of the presentexample comprises a non-extensible balloon (44) located just proximal toopen distal end (42) of dilation catheter (40). Balloon (44) is in fluidcommunication with inflation source (14). Inflation source (14) isconfigured to communicate fluid (e.g., saline, etc.) to and from balloon(44) to thereby transition balloon (44) between a non-inflated state andan inflated state. FIG. 1C shows balloon (44) in a non-inflated state.FIG. 1D shows balloon (44) in an inflated state. In the non-inflatedstate, balloon (44) is configured to be inserted into a constrictedanatomical passageway. In the inflated state, balloon (44) is configuredto dilate the anatomical passageway in which balloon (44) is inserted.Other features and operabilities that may be incorporated into dilationcatheter (40) will be apparent to those of ordinary skill in the art inview of the teachings herein.

II. Exemplary Image Guided Surgery Navigation System

FIG. 2 shows an exemplary IGS navigation system (100) enabling an ENTprocedure to be performed using image guidance. In some instances, IGSnavigation system (100) is used during a procedure where dilationinstrument assembly (10) is used to dilate the ostium of a paranasalsinus; or to dilate some other anatomical passageway (e.g., within theear, nose, or throat, etc.). In addition to or in lieu of having thecomponents and operability described herein IGS navigation system (100)may be constructed and operable in accordance with at least some of theteachings of U.S. Pat. No. 8,702,626, entitled “Guidewires forPerforming Image Guided Procedures,” issued Apr. 22, 2014, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,320,711, entitled “Anatomical Modeling from a 3-D Image and a SurfaceMapping,” issued Nov. 27, 2012, the disclosure of which is incorporatedby reference herein; U.S. Pat. No. 7,720,521, entitled “Methods andDevices for Performing Procedures within the Ear, Nose, Throat andParanasal Sinuses,” issued May 18, 2010, the disclosure of which isincorporated by reference herein; U.S. Pat. Pub. No. 2014/0364725,entitled “Systems and Methods for Performing Image Guided Procedureswithin the Ear, Nose, Throat and Paranasal Sinuses,” published Dec. 11,2014, now abandoned, the disclosure of which is incorporated byreference herein; U.S. Pub. No. 2016/0310042, entitled “System andMethod to Map Structures of Nasal Cavity,” published Oct. 27, 2016,issued as U.S. Pat. No. 10,362,965 on Jul. 30, 2019; and U.S. Pat. Pub.No. 2011/0060214, entitled “Systems and Methods for Performing ImageGuided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,”published Mar. 10, 2011, now abandoned, the disclosure of which isincorporated by reference herein.

IGS navigation system (100) of the present example comprises a fieldgenerator assembly (200), which comprises set of magnetic fieldgenerators (206) that are integrated into a horseshoe-shaped frame(204). Field generators (206) are operable to generate alternatingmagnetic fields of different frequencies around the head of the patient.Field generators (206) thereby enable tracking of the position of anavigation guidewire (130) that is inserted into the head of thepatient. Various suitable components that may be used to form and drivefield generators (206) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

In the present example, frame (204) is mounted to a chair (300), withthe patient (P) being seated in the chair (300) such that frame (204) islocated adjacent to the head (H) of the patient (P). By way of exampleonly, chair (300) and/or field generator assembly (200) may beconfigured and operable in accordance with at least some of theteachings of U.S. Patent App. No. 62/555,824, entitled “Apparatus toSecure Field Generating Device to Chair,” filed Sep. 8, 2017, thedisclosure of which is incorporated by reference herein.

IGS navigation system (100) of the present example further comprises aprocessor (110), which controls field generators (206) and otherelements of IGS navigation system (100). For instance, processor (110)is operable to drive field generators (206) to generate electromagneticfields; and process signals from navigation guidewire (130) to determinethe location of a sensor in navigation guidewire (130) within the head(H) of the patient (P). Processor (110) comprises a processing unitcommunicating with one or more memories. Processor (110) of the presentexample is mounted in a console (116), which comprises operatingcontrols (112) that include a keypad and/or a pointing device such as amouse or trackball. A physician uses operating controls (112) tointeract with processor (110) while performing the surgical procedure.

A coupling unit (132) is secured to the proximal end of a navigationguidewire (130). Coupling unit (132) of this example is configured toprovide wireless communication of data and other signals between console(116) and navigation guidewire (130). While coupling unit (132) of thepresent example couples with console (116) wirelessly, some otherversions may provide wired coupling between coupling unit (132) andconsole (116). Various other suitable features and functionality thatmay be incorporated into coupling unit (132) will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

Navigation guidewire (130) may be used as a substitute for guidewire(30) in dilation instrument (20) described above. Navigation guidewire(130) includes a sensor (not shown) that is responsive to movementwithin the fields generated by field generators (206). In the presentexample, the sensor of navigation guidewire (130) comprises at least onecoil at the distal end of navigation guidewire (130). When such a coilis positioned within an electromagnetic field generated by fieldgenerators (206), movement of the coil within that magnetic field maygenerate electrical current in the coil, and this electrical current maybe communicated along the electrical conduit(s) in navigation guidewire(130) and further to processor (110) via coupling unit (132). Thisphenomenon may enable IGS navigation system (100) to determine thelocation of the distal end of navigation guidewire (130) within athree-dimensional space (i.e., within the head (H) of the patient (P)).To accomplish this, processor (110) executes an algorithm to calculatelocation coordinates of the distal end of navigation guidewire (130)from the position related signals of the coil(s) in navigation guidewire(130).

Processor (110) uses software stored in a memory of processor (110) tocalibrate and operate system (100). Such operation includes drivingfield generators (206), processing data from navigation guidewire (130),processing data from operating controls (112), and driving displayscreen (114). Processor (110) is further operable to provide video inreal time via display screen (114), showing the position of the distalend of navigation guidewire (130) in relation to a video camera image ofthe patient's head (H), a CT scan image of the patient's head (H),and/or a computer generated three-dimensional model of the anatomywithin and adjacent to the patient's nasal cavity. Display screen (114)may display such images simultaneously and/or superimposed on each otherduring the surgical procedure. Such displayed images may also includegraphical representations of instruments that are inserted in thepatient's head (H), such as navigation guidewire (130), such that theoperator may view the virtual rendering of the instrument at its actuallocation in real time. By way of example only, display screen (114) mayprovide images in accordance with at least some of the teachings of U.S.Pub. No. 2016/0008083, entitled “Guidewire Navigation for Sinuplasty,”published Jan. 14, 2016, issued as U.S. Pat. No. 10,463,242 on Nov. 5,2019, the disclosure of which is incorporated by reference herein. Inthe event that the operator is also using an endoscope, the endoscopicimage may also be provided on display screen (114).

The images provided through display screen (114) may help guide theoperator in maneuvering and otherwise manipulating instruments withinthe patient's head (H). When used as a substitute for guidewire (30) indilation instrument assembly (10), navigation guidewire (130) mayfacilitate navigation of instrumentation of dilation instrument assembly(10) within the patient during performance of a procedure to dilate theostium of a paranasal sinus; or to dilate some other anatomicalpassageway (e.g., within the ear, nose, or throat, etc.). It should alsobe understood that other components of dilation instrument assembly (10)may incorporate a sensor like the sensor of navigation guidewire (130),including but not limited to dilation catheter (40).

III. Exemplary Integration of Navigation Controls with MedicalInstrument

Many medical instruments, such as dilation instrument (20), describedabove, suction instrument (602), shown in FIG. 14 and described below,and debriding instrument (1000) shown in FIG. 19 and described below,may be used in medical procedures aided by an IGS navigation system(100). These medical instruments may have various controls built intothe grips or body of the device to allow end effectors, guidewires, orother device features to be activated, deployed, or otherwisemanipulated during a medical procedure. Since they are located on thegrips or body of the device, these controls may be quickly and easilyinteracted with by a clinician during a procedure, often without beingrequired to shift their focus from a patient or move to a differentposition within the procedure room. Some such actuation features arepositioned and configured to be manipulated by the same hand that graspsthe medical instrument, such that the medical instrument is configuredto enable full operation by a single hand.

Conversely, conventional IGS navigation systems (100) may requireinteraction with operating controls (112) such as a mouse, keyboard, orother generic interface device in order to allow navigation through thevarious images, views, or other data sources offered by the IGSnavigation system (100). In conventional IGS navigation systems (100),such operating controls (112) may be spaced away from the clinicianoperating the medical instrument (e.g., dilation instrument (20),suction instrument (602), etc.); and may be in a non-sterile field.Thus, while a clinician performing a procedure may be able to view adisplay screen (114) or other visual output device of an IGS navigationsystem (100), the mouse, keyboard, or other operating control (112) maybe outside of the reach of the clinician operating the medicalinstrument. This means that, in order for a clinician to directlynavigate the views offered by an IGS navigation system (100), which mayinvolve navigating with six degrees of freedom (e.g., moving in any ofthree directions within three-dimensional space, rotating in any ofthree within three-dimensional space), the clinician would have to leavethe sterile field of the procedure room. This may be undesirable if notimpossible, and, as a result, direct navigation via operating controls(112) by a clinician who is also manipulating the medical instrument maynot be feasible.

Instead of having direct control over operating controls (112),clinicians who operate the medical instrument (e.g., dilation instrument(20), suction instrument (602), etc.) in the patient may relaynavigation instructions to a separate person manipulating operatingcontrols (112) of IGS navigation system (100) as navigation is needed.Even directly shifting a viewpoint within a three-dimensional set ofimages to locate a desired perspective can be a complex task. Having todo so by relaying voice instructions to an operator may increase therequired time and risk of error associated with this already complextask.

Addressing these shortcomings may present its own difficulties. Whenmodifying a medical instrument, many factors must be considered.Considerations may include weight, ergonomics, cost, compatibility withsterile packaging and storage, compatibility with sterilizationprocedures, presence of metallic components, availability of a powersource, and other considerations. Discussed below are severalimplementations that have may provide advantageous integral controls toa medical instrument while also balancing these other considerations.

A. Image Guided Surgery Navigation with Navigation Wheel

FIG. 3 shows a dilation instrument (400) representing a modified versionof dilation instrument (20). Thus, except as otherwise described below,dilation instrument (400) may be configured and operable just likedilation instrument (20). Dilation instrument (400) of this exampleincludes a handle assembly (402) and a guide catheter (404) projectingdistally from handle assembly (402). Dilation instrument (400) furtherincludes a horizontal navigation wheel (410) and a vertical navigationwheel (430) integrated into handle assembly (402).

Each navigation wheel (410, 430) is in communication with acommunication module (450), which is configured to provide communicationbetween navigation wheels (410, 430) and processor (110) of IGSnavigation system (100). In some versions, communication module (450)provides wireless communication with processor (110). Such wirelesscommunication may be provided via radio (e.g., Bluetooth, wi-fi),optical (e.g., infra-red), sonic (e.g., ultrasonic transmission),induction (e.g, RFID), or otherwise. In some other versions,communication module (450) provides wired communication with processor(110). Various suitable forms that communication module (450) may takewill be apparent to those of ordinary skill in the art in view of theteachings herein.

Navigation wheels (410, 430) provide additional input options for aclinician using the dilation instrument (400), which may includescrolling or rotating the wheel in either direction, clicking ordepressing the wheel downwardly like a button, tilt-clicking the wheelin either direction like a switch, and combinations of the above. Theseadditional inputs may be communicated to an IGS navigation system (100)via communication module (450) to allow interaction with that system,and may allow a clinician using the dilation instrument (400) to changethe configuration of the IGS navigation system (100), change theirperspective and navigate the views offered by display screen (114), andother similar interactions.

Inputs from navigation wheels (410, 430) may be configured to providevarious interactions with the IGS navigation system (100), and may beinterpreted differently by an IGS software application as compared to anoperating system that is configured on the IGS navigation system (100).As an example, scrolling or rotating a horizontal navigation wheel (410)in a first direction may move a mouse cursor of the IGS navigationsystem (100) in the first direction when an IGS software application isnot currently being focused on. The same input may also move a mousecursor when the IGS software is being focused on to allow interactionwith the IGS software via a mouse cursor, or, in some implementations,may rotate a viewing perspective in three-dimensional space in the firstdirection.

Additionally, rotating, clicking, or tilting of the navigation wheels(410, 430) may be interpreted by the IGS navigation system (100) or itssoftware applications as various types of mouse button inputs (e.g.,right click, left click), keyboard inputs (e.g., ctrl, alt, shift,space), or custom inputs (e.g., zoom in, zoom out, minimize to desktop,open a menu, save, close, or load image sets). Combined inputs may alsobe interpreted differently by an IGS navigation system (100) operatingsystem or application. For example, depressing or tilting a horizontalnavigation wheel (410) while rotating a vertical navigation wheel (430)may be configured to zoom in when the vertical navigation wheel (430) isrotated in a first direction; or zoom out when vertical navigation wheel(430) is rotated in a second direction. Depressing or tilting thevertical navigation wheel (430) while the horizontal navigation wheel(410) is rotated may be configured with a different functionality, suchas rotating a perspective within three-dimensional space in the first orsecond direction.

It will be apparent to one skilled in the art, in light of thisdisclosure, that combining these inputs in different ways provides agreat variety of unique inputs. As an example, in one implementationhaving two navigation wheels (410, 430) that each may be rotated in afirst direction and a second direction, and may also be clicked ordepressed, there are six unique single button inputs and fifteen uniquetwo button inputs, providing more than twenty total unique input optionsfrom just two navigation wheels (410, 430). Rotational speed of anavigation wheel (410, 430) may also be an input, with the speed ofrotation scaling along with the speed of a resulting perspectiverotation or zoom operation; or rotational speed thresholds may be usedto determine that a slow rotation is a first unique input, a moderaterotation is a second unique input, and a fast rotation is a third uniqueinput.

A navigation wheel (410, 430) may be implemented in a variety of ways.FIG. 4 shows one example that may be desirable for integration with amedical instrument due to its simplicity and impact on weight and cost.The navigation wheel (410) of FIG. 4 is appropriate for use as eitherhorizontal navigation wheel (410) or a vertical navigation wheel (430).Navigation wheel (410) of this example comprises an outer annular member(412) having a series of spokes (414) radiating from a hub (416). Eachspoke (414) has a first conductive face (420) and a second conductiveface (422), with each conductive face (420, 422) being connected to anelectrical supply of a different voltage. For example, the firstconductive face (420) may be connected to a 1-volt electrical supply,and the second conductive face (422) may be connected to a 5-voltelectrical supply. The electrical supply may be delivered by a shaft(460), shown in FIG. 5, that comprises a first conductive portion (462),a second conductive portion (464) and a non-conductive portion (466).

The shaft (460) fits within the hub (416), as shown in FIG. 6, and thefirst conductive portion (462) supplies a 1-volt electrical supply tothe first conductive face (420) of each spoke (414). Similarly, thesecond conductive portion (464) supplies a 5-volt electrical supply tothe second conductive face (422) of each spoke (414). The non-conductiveportion (464) separates and the two conductive portions (462, 464) and,in some versions, may also have additional non-conductive materialsseparating the two; may be attached to the hub (416) so that the shaft(460) rotates with the annular member (412); or may rest within the hub(416) and allow the annular member (412) to rotate freely about theshaft (460).

FIG. 6 also shows a flexible conductive pin (470) that extends into thespace between spokes (414). As the annular member (412) rotates, theflexible conductive pin (470) will be struck by the first conductiveface (420) when the annular member (412) rotates in the first direction,and transmit, for example, a 1-volt electrical supply through theflexible conductive pin (470); or will be struck by the secondconductive face (422) when the annular member (412) rotates in thesecond direction, and transmit, for example, a 5-volt electrical supplythrough the flexible conductive pin (470). Variation in the voltagesupplied to the flexible conductive pin (470) may be chosen based uponfactors that will be apparent to one skilled in the art. For example, insome medical instruments a 1-volt and 5-volt electrical supply mayalready be present in current designs for other purposes, and may beeasily utilized as part of a signal generator for a navigation wheel(410, 430).

In operation, the navigation wheel (410) of FIGS. 4-6 will, as it isrotated by a user, generate a series of electrical signals indicatingboth the direction of rotation, as well as the speed of rotation. Thisseries of signals can be interpreted by a controller (not shown) that isused by other features of dilation instrument (400), or that isdedicated for navigation wheel (410) operation. This controller mayprovide the signal set directly to communication module (450) that is incommunication with the IGS navigation system (100), or may be performvarying levels of manipulation (e.g., filtering, encoding, interpreting,etc.) before doing so. Once received by the IGS navigation system (100),the information may be used to provide some level of control over thesoftware of the IGS navigation system (100).

Some factors to consider in implementing a navigation wheel (410, 430)such as that shown in FIGS. 3-6 may include reusability and ease ofsterilization. Some medical instruments may undergo deep sterilizationtreatments after each use so that they may be re-used a limited numberof times. Thus, some navigation wheel (410, 430) implementations mightinclude materials or other design choices that either prevent the needfor sterilization of the wheel components (e.g., sealing the edges ofthe medical instrument where the wheel is installed or manufacturingcomponents from sterile or antimicrobial materials), or improve theability of conventional sterilization techniques to sterilize theassembly (e.g., exposing all of the non-sterile portions of the wheelassembly so that sterilant may easily enter). Various features andconfigurations that may be incorporated into or otherwise associatedwith navigation wheels (410, 430) to accommodate sterilization will beapparent to those of ordinary skill in the art in view of the teachingsherein.

While the above discussion has focused on the integration of navigationwheels (410, 430) with dilation instrument (400), it should beunderstood that the components and features of navigation wheel (410,430) may be integrated with a variety of medical instruments beyonddilation instrument (400), including, for example, suction instrument(602).

B. Image Guided Surgery Navigation with Control Overlay

FIGS. 7-9 show another implementation of integral controls that may beused with a medical instrument, such as the dilation instrument (20).The control overlay (500) of FIG. 7 is designed and shaped to be placedonto the control area of the dilation instrument (20), though it mayalso fit other medical instruments either in the shown form, or withsome changes. The control overlay (500) comprises an overlay body (502),upon which are mounted a pointing stick (504), which can be used like ajoystick to provide inputs in a variety of directions (e.g., 4directions, 8 directions, 16 directions, etc.), two midpoint buttons(508, 510), and two end buttons (512, 514), which can be pressed toprovide input unique to that button. The control overlay (500) alsocomprises two cutouts (506) that finger-grips (70) of the dilationinstrument (20) may pass through when the control overlay (500) isinstalled, as shown in FIG. 11.

FIGS. 10 and 11 each show the underside of a dilation instrumentassembly (10), with the control overlay (500) removed in the former, andinstalled in the latter. As can be seen, the control overlay (500) is ofa length that allows it to fit between two outer finger-grips (72), andthe cutouts (506) are positioned to allow it to slip over top of twoinner finger-grips (70). The control overlay (500) is curved andcontoured to substantially match the shape of the handle body (22),allowing the control overlay (500) to snugly fit against the handle body(22) when installed. This can also be seen in the rear contour (516) ofthe control overlay (500) in FIG. 9.

The control overlay (500) may be installed in a variety of ways. Forexample, in some implementations, the overlay body (502) may fit snuglybetween the outer finger-grips (72) such that it is held in place viafriction during normal use. The edge of the overlay body (502) thatcontacts the outer finger-grips (72) may be constructed from or coveredwith an elastomeric material such as rubber or soft plastic, or have arough, textured, or adhesive surface, in order to improve holdingability when installed in this manner. In other implementations, thecontrol overlay (500) may be attached by way of adhesive strips or padswithin the rear contour (516). In other implementations, the controloverlay (500) may mechanically attach by way of clips or flexibleplastic or spring-loaded catches that cause it to snap into receiverportions of the grip body (22) when pressed into position between theouter finger-grips (72). In other implementations, the control overlay(500) may be attached by way of a magnetic connection between thecontrol overlay (500) and the grip body (22). Other ways in which thecontrol overlay (500) could attach to the dilation instrument assembly(10) will be apparent to one skilled in the art in light of thisdisclosure.

As with previously discussed examples of integral controls, the pointingstick (504) and buttons (508, 510, 512, 514) of the control overlay(500) may be used singularly, or in combination with each other toprovide a variety of unique inputs that can be interpreted by the IGSnavigation system (100) software to provide control. As with priorexamples of integral controls, inputs provided to the control overlay(500) by a user may be provided to the IGS navigation system (100) via awireless connection (e.g., Bluetooth), or a wired connection (e.g., aUSB connection present on the control overlay (500) or shared with themedical instrument).

While the control overlay (500) of FIGS. 7-9 is shaped to fit thedilation instrument assembly (10), it should be understood that the sizeand shape of the overlay body (502) and the position and assembly ofcomponents therein (e.g., button mechanisms, flexible Bluetoothtransceiver circuit, etc.) may be varied in order to fit any medicalinstrument, or to provide more space within the hollow overlay body(502) for internal components (e.g., a larger battery or a hapticfeedback device).

Reusability factors that may be considered in implementing an overlaycontrol (500) might result in some implementations being produced at acost that allows them to be disposable, removing the need forsterilization, or by providing an overlay body (502) that is entirelysealed to prevent the entry of bacteria or sterilant.

While the above discussion has focused on the control overlay (500) withdilation instrument (10), it should be understood that the componentsand features of control overlay (500) may be implemented and used with avariety of medical instruments beyond dilation instrument (10),including, for example, suction instrument (602).

C. Image Guided Surgery Navigation with Control Clip

FIGS. 12A, 12B, and 13 show an implementation of an exemplary controlclip (1200) that may be used as a retrofit with a surgical instrument,such as dilation instrument (20), to provide additional controls thatmay be configured to interact with a system such as the IGS navigationsystem (100). The control clip (1200) may be contoured and shaped to fiton a portion of a surgical instrument, such as the dilation catheterslider (28) of the dilation instrument (20), as can be seen in FIG. 13.Placement of the control clip (1200) on the dilation catheter slider(28) may advantageously position the control clip (1200), and a controlmodule (1202) including a set of buttons or other controls, so that itis readily accessible by a user of the dilation instrument (20) tointeract with the IGS navigation system (100) in order to change orinteract with a software or interface shown on the display screen (114),change the operation or configuration of a surgical instrument, or otherinteractions.

The control clip (1200) of this example includes a first clamp arm(1205) and a second clamp arm (1206) connected by a device saddle(1204). The device saddle (1204) may be sized and contoured to fit overthe grip portion of the dilation catheter slider (28), with the firstclamp arm (1205) and the second clamp arm (1206) fitting on either side.In some implementations, the control clip (1200) may be constructed fromresilient materials such as plastic that allow it to be fit over thedilation catheter slider (28) such that the first clamp arm (1205) andthe second clamp arm (1206) are pushed outwardly, while being flexiblybiased toward their original state, resulting in a friction fit or snapfit of the control clip (1200) on the dilation catheter slider (28). Insome implementations, the interior side of the control clip (1200) thatcontacts the dilation catheter slider (28) may include adhesives, highfriction flexible foams or other elastomeric material, mechanicalcatches that align and attach to corresponding features of the dilationcatheter slider (28), or other clips, fasteners, or connectors that aidin maintaining a connection of the control clip (1200) to the dilationcatheter slider (28). The control clip (1200) may also include otherattachment features such as described above in the context of thecontrol overlay (500), including textured surfaces, spring loadedcatches, clips, and magnetic connections. Varying implementations mayinclude one or more of the above attachment features, such as a controlclip (1200) that is rigid but that includes an adhesive on the interiorportion so that it can be temporarily adhered to the dilation catheterslider (28), or such as a control clip (1200) that is flexibly biasedand includes high friction rubbers on the interior portion to aid inachieving a high friction connection to the dilation catheter slider(28).

The control clip (1200) of the present example also includes a controlmodule (1202), which itself includes a first button (1208), a secondbutton (1210), and a third button (1212). While the control module(1202) of FIG. 12A includes three buttons, it should be understood thatvarying implementations may include other numbers and types of controls,including, for example, navigational wheels (e.g., such as thenavigation wheels (410, 430)), proximity or touch controls (e.g., suchas shown in FIG. 15 and described below), sand other input types. Aswith previously discussed examples, the first button (1208, secondbutton (1210), and third button (1212) may be used singularly, or incombination with each other to provide a variety of unique inputs thatcan be interpreted by the IGS navigation system (100) to allow controland interaction with the navigation software or other software orinstruments. Inputs provided via interactions with the buttons or othercontrols of the control module (1202) may be provided to the IGSnavigation system (100) via a wireless connection (e.g., Bluetooth,Wi-Fi, optical transmission), or a wired connection (e.g., a USBconnection or other data connections present on the control overlay(500) or shared with the medical instrument).

While the control clip (1200) is shaped to fit the dilation catheterslider (28), it should be understood that the size and shape of thecontrol clip (1200) may be varied to fit other medical instruments, toincrease the size of the control module (1202) to provide more exteriorsurface for input controls, or additional space for internal componentssupporting such exterior controls. The control clip (1200) may also beimplemented such that it may be disposed of after one or several uses,with such implementations including one or more low cost components suchas simple actuation buttons, short range wireless communicationcomponents, low capacity batteries, and simple attachment features suchas adhesives or elastomeric rubber. Some implementations may be designedfor reusability; and may include one or more features such as thecontrol module (1202) being sealed to prevent contamination during useor damage during sterilization procedures, a rechargeable battery, arigid body that will not change shape or lose flexibility from exposureto heat, and attachments features such as mechanical catches, clips, orspring loaded switches.

D. Image Guided Surgery Navigation with Touch Sensors

FIG. 14 shows a suction instrument assembly (600) comprising a suctioninstrument (602) and suction source (612). Suction source (612) isconnected to a suction port (611) of suction instrument (602) such thatsuction provided by suction source (612) is capable of producing suctionthrough a suction cannula (604) of the suction instrument (602). In thismanner, suction instrument (602) may be used during a medical procedureto remove various fluids or other materials from a procedure area andtransport them, via the suction path (not pictured) of the suctioninstrument (602), the suction path (not pictured) comprising a channelthat runs from suction cannula (604), through grip portion (606) throughsuction port (611) and to a disposal destination downstream of thesuction port (611). Suction instrument (602) further comprises a gripportion (606) adapted to be held by a user of the suction instrument(602) during use, the grip portion (606) itself comprising a controlvent (608). Control vent (608) is connected to suction path (notpictured) defined in grip portion (606) between suction cannula (604)and suction port (611) such that suction provided by suction source(612) may produce variable amounts of suction through control vent (608)and suction cannula (604) depending upon full coverage, partialcoverage, or non-coverage of control vent (608) by a finger, thumb, orother surface of a user.

Suction instrument (602) is in communication with IGS navigation system(100) via a connector (613) that attaches to a port (609) of the suctioninstrument (602) to allow communication between the suction instrument(602) and the IGS navigation system (100). In some implementations,suction instrument (602) may also receive electrical power via the port(609) and the connector (613). Suction instrument (602) is configured toprovide information to the IGS navigation system (100) that can be usedto execute an algorithm to calculate location coordinates of one or moreportions of suction instrument (602). For instance, a sensor like thesensor of navigation guidewire (130) may be positioned at the distal endof suction cannula (604). IGS navigation system (100) may processsignals from the sensor of suction instrument (102) such that IGSnavigation system (100) may calculate, track, and display the spatiallocation of suction cannula (604) relative to a three-dimensional modelof the anatomy within or adjacent to a patient's nasal cavity.

As with other uses of the IGS navigation system (100), it may beadvantageous to provide controls for the IGS navigation system (100)that are integrated with or otherwise located proximately to the suctioninstrument (602). Due to the relatively small size of suction instrument(602) and grip portion (606) in particular, as well as the placement andfunction of control vent (608), it may be advantageous to provide suchcontrols for IGS navigation system (100) having a reduced size such thatinternal space and external space required for integrating the controlsare minimized. Such controls could be more flexibly integrated withsurgical instruments such as suction instrument (602) while notinterfering with the primary function and features of the instrument,such as control vent (608) and suction path (not pictured).

FIG. 15 shows a schematic diagram of an exemplary proximity sensor(700). The proximity sensor (700) comprises an optical transmitter (706)that is operable to project a light (702) at a target (704) and anoptical receiver (708) that is operable to receive the light (702) as itreflects off the target (704). The light (702) may be transmitted andreceived through a cover (701) of the proximity sensor (700) that isconfigured to allow the light (702) to pass while also providingprotection to internal components of the proximity sensor (700). Acontroller (710) of the proximity sensor (700) is configured to controlthe optical transmitter (706) and receive data from the optical receiver(708) indicating characteristics of the light (702) as it is received.Characteristics may include, for example, intensity of the reflectedlight, angle of the reflected light, a received portion of reflectedlight (e.g., where the target (704) is positioned to reflect some butnot all of the light projected by the optical transmitter (706)), ortime between transmission and receipt. Such data may then be used by thecontroller (710) or be provided to another device via an input outputinterface (712), to calculate and determine the distance between theproximity sensor (700) and the target (704).

While proximity sensor (700) is in the form of an optical sensor in thepresent example, proximity sensor (700) may alternatively take variousother forms. By way of example only, proximity sensor may comprise acapacitive sensor and/or any other suitable kind of proximity sensor.Other suitable examples will be apparent to those skilled in the art inview of the teachings herein.

The input output interface (712) may be a physical or wirelessconnection with another device or component, and may include, forexample, a conductive connection capable of transmitting electricalsignals, or a wireless transceiver capable of wireless communicationwith other devices. In some implementations, the proximity sensor (700)may be provided power via the input output interface (712), or may usean integral battery, or both. Operating in this manner, the proximitysensor (700) may provide a signal to another device or component via theinput output interface (712) that indicates a verified presence of thetarget (704) within a detectable distance, the distance between thetarget (704) and the proximity sensor (700), or both.

In the context of integrated controls having a minimized sizerequirement, the proximity sensor (700) may be used to generate signalsindicating the presence of a user's finger or other object that istouching or proximate to the proximity sensor (700); and communicatethose signals via the input output interface (712) to a surgicalinstrument, IGS navigation system (100), or both. Such an indicationcould be interpreted as a user interaction with the integrated control,similarly to the pressing of a button, scrolling of a wheel, or othersimilar interfaces. The proximity sensor (700) may offer severaladvantages in such an implementation. For example, due to its relativelack of complexity and low power requirement, the proximity sensor (700)may be implemented having a small size requirement and trivial weight;and can be integrated with a surgical instrument such as the suctioninstrument (602) without significantly impacting its overall weight orpower requirements, and without significantly impacting usabilityfactors such as the size or shape of the grip portion (606), or the sizeor placement of the control vent (608).

The proximity sensor (700) may also be an advantageous control forsurgical instruments such as the suction instrument (602) since itrelies upon the transmission of light, which may pass through the cover(701) without impacting the performance of the proximity sensor (700).Thus, the cover (701) may seal and protect the internal portions of theproximity sensor (700) against outside liquids, gasses, or contaminantswithout preventing its function. In the context of surgical instruments,this may be advantageous to preserve sterility of a surgical instrumentby preventing contaminants from undesirably entering or being depositedin a crack, seam, or other internal cavity of the surgical instrumentbefore or during a procedure. This may also advantageously protect thecomponents of the proximity sensor (700) during sterilization orreprocessing treatments of the surgical instrument before or after aprocedure, which may cause sterilant, detergent, or other substances tobe applied to the surgical instrument at varying pressures andtemperature, which could otherwise damage or otherwise negatively impactthe controller (710), optical transmitter (706), optical receiver (708),input output interface (712), or other components of the proximitysensor (700).

As an example of a surgical instrument with an integrated controlsimilar to the proximity sensor (700) of FIG. 15, FIG. 16 shows anexemplary suction instrument (800) with a proximity control (812). Thesuction instrument (800) has a similar function and design as thesuction instrument (602), and comprises a grip portion (802), a suctioncannula (804), a control vent (806), a suction port (808), and anavigation port (810), each having a similar function as thecorresponding components of the suction instrument (602). The proximitycontrol (812) is positioned proximate to the control vent (806), toallow a user of the suction instrument (800) to swiftly alternatebetween covering some or all of the control vent (806) with a finger, tointeracting with the proximity control (812) with the same or adifferent finger. The small size of the proximity control (812), both onthe exterior and interior of the suction instrument (800), allows it tobe integrated with the grip portion (802) without impacting theusability of the control vent (806), and without obstructing the flow ofsuctioned materials passing through the grip portion (802).

While FIG. 16 shows the proximity control (812) positioned on the top ofthe grip portion (802), proximity control (812) may also be positionedon a side or bottom of the grip portion (802), as may be desired.Similarly, while proximity control (812) is distal to control vent (806)in this example, proximity control (812) may instead be proximal tocontrol vent (806).

The proximity control (812) may be coupled with the port (810) viacircuitry embedded in the grip portion (802) such that it receives powerand exchanges data with a device such as the IGS navigation system (100)that may be connected to the port (810) during use. In this manner,signals generated by a user's interactions with the proximity control(812) may be communicated to the IGS navigation system (100) as userinputs. These user inputs allow interaction with IGS navigation system(100), and may allow a clinician using the suction instrument (800) tochange the configuration of the IGS navigation system (100), changetheir perspective and navigate the views offered by display screen(114), and other similar interactions. As with prior examples, theseinputs may also be configured to provide various interactions with theIGS navigation system (100) depending upon factors such as the number,pattern, timing, and other characteristics of the inputs.

As an example, tapping the proximity control (812) once might cause theIGS navigation system (100) to proceed to a next view or image in a setof images, while double tapping the proximity control (812) might causethe IGS navigation system (100) to return to a prior view or image. Aninput from tapping the proximity control (812) and maintaining the tapfor a period of time may cause the IGS navigation system (100) torapidly iterate through a set of views or images, or alternatingly zoomin and zoom out from a current view. A single tap followed by moving afinger to variable distances from the proximity control (812) may causethe IGS navigation system (100) to zoom to various levels ofmagnification of an image dependent upon the distance of the finger fromthe proximity control (812). With implementations where the proximitycontrol (812) can detect partial coverage by an object (e.g., a fingertap or touch covering only half of the proximity control (812)), userinputs could also include swiping across the proximity control (812) indifferent directions to control a mouse pointer, rotate a view or image,or scroll along a view or image. Other possible inputs and variations ofinputs exist for the suction device (800) and IGS navigation system(100) and will be apparent to one skilled in the art in light of thisdisclosure.

FIG. 17 shows another exemplary suction instrument (900) with anintegrated control comprising a set of proximity sensors (912) similarto the proximity sensor (700). The suction instrument (900) has asimilar function and design as the suction instrument (602) and suctioninstrument (800), and comprises a grip portion (902), an exemplarymedical procedure feature shown as a suction cannula (904), a controlvent (906), a suction port (908), and a navigation port (910), eachhaving a similar function as the corresponding components of suctioninstrument (602, 800). An exemplary set of controls shown as a proximitycontrol cluster (912) is positioned on the grip portion (902), to allowa user of the suction instrument (900) to swiftly alternate betweencovering some or all of the control vent (906) with a finger, tointeracting with the proximity control cluster (912) with the same or adifferent finger. As with the suction instrument (800), the small sizeof the proximity control cluster (912), both on the exterior andinterior of the suction instrument (900), allows it to be integratedwith the grip portion (902) without impacting the usability of thecontrol vent (906), and without obstructing the flow of suctionedmaterials passing through the grip portion (902).

While FIG. 17 shows the proximity control cluster (912) positioned onthe top of the grip portion (902), proximity control cluster (912) mayalso be positioned on a side or bottom of the grip portion (902), as maybe desired. Similarly, while proximity control cluster (912) is proximalto control vent (906) in this example, proximity control cluster (912)may instead be distal to control vent (906).

As with the suction instrument (800), the proximity control cluster(912) may be coupled with the port (910) via circuitry embedded in thegrip portion (902) such that it receives power and exchanges data with adevice such as the IGS navigation system (100) that may be connected tothe port (910) during use. In this manner, signals generated by a user'sinteractions with the proximity control cluster (912) may becommunicated to the IGS navigation system (100) as user inputs. Theseuser inputs allow interaction with that system and may allow a clinicianusing the suction instrument (900) to change the configuration of theIGS navigation system (100), change their perspective and navigate theviews offered by display screen (114), and other similar interactions.As with prior examples associated with the suction instrument (800),these inputs may also be configured to provide various interactions withthe IGS navigation system (100) depending upon factors such as thenumber, pattern, timing, and other characteristics of the inputs.

As an example, since the proximity control cluster (912) pictured inFIG. 17 has four separate proximity sensors similar to the proximitysensor (700), arranged in a diamond pattern with each sensor beingassociated with a direction (e.g., left, right, up, down), a touch ortap on an individual proximity sensor of the proximity control cluster(912) could cause the IGS navigation system to move a mouse cursor inthat direction, or to navigate, scroll, or zoom images or views.Patterns of taps could also cause certain resulting actions by the IGSnavigation system (100). For example, sensor tapping pattern of left,right, left, right might cause the IGS navigation system (100) to returnto a pre-set view or perspective, while a pattern of up, down, up, down,may cause the IGS navigation system (100) to save a current view orperspective as the pre-set view or perspective. The proximity controlcluster (912) may also support a scrolling motion across the cluster(912) to cause the view or perspective to scroll, rotate, or zoom, or aclockwise or counter-clockwise rotational motion around the perimeter ofthe proximity control cluster (912) to cause the view or perspective torotate or zoom. The proximity control cluster (912) could also receiveas input various motions or movements of an object within a detectabledistance above the proximity control cluster (912) so that, for example,a tap of the entire proximity control cluster (912) followed by themovement of that finger in three dimensional space above the proximitycontrol cluster (912) could be used by the IGS navigation system (100)to similarly move a viewing perspective through the three dimensionalspace of a navigational image set. Other possible inputs and variationsof inputs exist for the suction device (900) and IGS navigation system(100) and will be apparent to one skilled in the art in light of thisdisclosure.

E. Image Guided Surgery Navigation with Integrated Controls

FIGS. 18 and 19 show additional implementations of surgical instrumentsincluding integrated controls that may be configured to interact with asystem such as the IGS navigation system (100). FIG. 18 shows aperspective view of an exemplary suction instrument (1100), havingsimilar function to previously discussed suction instruments (e.g., thesuction instrument (602) of FIG. 14, the suction instrument (800) ofFIG. 16, the suction instrument (900) of FIG. 17). The suctioninstrument (1100) includes a grip portion (1102), a suction cannula(1104), a control vent (1106), and a suction port (1108), each having asimilar function as the corresponding components of previous examples.The suction instrument (1100) also includes a first button (1110), asecond button (1112), and a third button (1114) disposed on the top andside of the grip portion (1102), with the internal components of suchbuttons being positioned within the grip portion (1102) such that theydo not interfere with the internal suction path of the surgicalinstrument (1100) (e.g., a channel (not pictured) that runs from thesuction port (1108), to the suction vent (1106), and then to the distaltip of the suction cannula (1104)).

FIG. 19 shows a perspective view of an exemplary debriding instrument(1000) having integrated IGS navigation controls. The debridinginstrument (1000) may be operable during a surgical procedure to cut orshave bone, tissue, and other materials. A grip body (1002) containselectrical and mechanical components that may receive power from aconnected power source (1006) in order to drive a cutting head (1008)which catches tissue and other materials between an inner rotatingcutting edge and an outer static cutting edge in order to cut or shavethe affected material. As an example, the debriding instrument (1000)may incorporate any of the teachings of U.S. patent application Ser. No.16/012,922, entitled “Surgical Shaver with Feature to Detect WindowState” filed Jun. 20, 2018, now abandoned, the disclosure of which isincorporated by reference herein; and/or U.S. Patent App. No.62/741,594, entitled “Hollow Tube Surgical Instrument with Single AxisSensor,” filed Oct. 5, 2018, the disclosure of which is incorporated byreference herein. The grip body (1002) also includes a handgrip (1004),as well as a first button (1010) and a second button (1012), positionedon the grip body (1002) and near the handgrip (1004), so that they maybe accessible while holding the debriding instrument (1000) during use.

With references to the suction instrument (1100), the first button(1110), the second button (1112), and the third button (1114) may beused singularly, or in combination with each other to provide a varietyof unique inputs that can be interpreted by the IGS navigation system(100) software or other software or devices of the IGS navigation system(100) to provide control, as has been previously described. Withreference to the debriding instrument (1000), the first button (1010)and the second button (1012) may be used singularly, or in combinationwith each other to provide a variety of unique inputs that can beinterpreted by the IGS navigation system (100) software or othersoftware or devices of the IGS navigation system (100) to providecontrol, as has been previously described. While described and shownherein as a press-button, it should be understood that any of thebuttons disclosed herein may instead be a rocker switch, slide switch,or other switch, a rotatable knob, pad, or other element, or othersimilar mechanical input.

For each instrument, inputs may be provided to the IGS navigation system(100) via a wireless connection (e.g., Bluetooth, Wi-Fi), or a wiredconnection (e.g., a data transmission via a physical connection such asa navigational guidewire capable of transmitting a signal from thesuction instrument (1100) to the coupling unit (132) or another device).As another example, the debriding instrument (1000) may be incommunication with the IGS navigation system (100) via the connection tothe power source (1006) or another attached device; and may provideinputs to the IGS navigation system (100) via that connection.

For each instrument, reusability factors may be considered whenimplementing integral controls, which may include sealing such controlsso that they are resistant to contamination with tissue, bacteria, orother materials, providing controls that may be sterilized during asterilization procedure without damage, and other similar techniques asdescribed herein, and as will be apparent to one of ordinary skill inthe art in light of this disclosure.

It should also be understood that the number, types, and positions ofcontrols show in FIGS. 18 and 19 are exemplary and, while they provideadvantages in terms of functionality and accessibility to a user duringuse of the associated instrument, other variations exist. For example,the suction instrument (1100) may include one or more proximity controls(e.g., such as the proximity control (812) or the proximity controlcluster (912)) instead of or in addition to any of the shown buttons.Similarly, the debriding instrument (1000) may include proximitycontrols (e.g., such as the proximity control (812) or the proximitycontrol cluster (912)), navigation wheels (e.g., such as the navigationwheels (410, 430)), control overlays (e.g., such as the control overlay(500) or the control clip (1200)), and other control features instead ofor in addition to any of the shown buttons.

F. Integration Module for Image Guided Surgery Navigation

FIG. 20 shows a schematic view of an exemplary integration module (1300)that may be integrated into a surgical instrument such as those shown inat least FIGS. 3, 11-13, and 16-20 to provide integration features witha system such as the IGS navigation system (100). Such integration mayinclude using one or more of the disclosed controls for changing theview of an IGS navigation software or interface displayed on the displayscreen (114), activating a device or device feature on a surgicalinstrument being used with the IGS navigation system (100), changing aconfiguration of a device or software in use with the IGS navigationsystem (100), and other features.

The integration module (1300) of this example includes a controlinterface (1302) that may be coupled with one or more controls (e.g.,buttons, navigation wheels, proximity controls) to receive user inputsprovided via those controls as electronic signals. The integrationmodule (1300) also includes a processor (e.g., a microprocessor, logiccircuit, or other electronic circuit) (1304) that may include or bepaired with a memory (e.g., an electronic storage), and that may receivesignals via the control interface (1302) so that they may be analyzed,processed, stored, acted upon, or transmitted to another device.Received signals may be provided to the IGS navigation system (100) asthey are received, or may be modified, encoded, converted, or compressedby the processor (1304) prior to transmission, such as where threediscrete signals are received via the control interface (1302)indicating that three separate buttons (e.g., the first button (1208),the second button (1210), and the third button (1212)) are beingpressed, and may be converted into one or more different signalsindicating a particular combination of pressed buttons.

The processor (1304) may also operate a communication device (1308) inorder to transmit received inputs to another device or system, such asthe processor (110), the coupling unit (132), or both, or another systemor device of the IGS navigation system (100). The communication device(1308) may be a wireless (e.g., Bluetooth, Wi-Fi) or wired (e.g., USB,data-over-power, or other data connection) connection as has beendescribed above in the context of each of the various the types ofintegral controls disclosed herein. This may include, for example, alow-energy Bluetooth transceiver, Wi-Fi transceiver, or other wirelesscomponent. In some implementations, the function of the communicationdevice (1308) may be performed partially or entirely by the couplingunit (132), such as where the coupling unit (132) receives inputsdirectly from the control interface (1302) and then transmits them tothe processor (110).

The integration module (1300) may also include a power source (1306),which may be a one-time use battery, rechargeable battery, or wiredpower source (e.g., power via USB) as may be desirable for a particularimplementation. For example, a device that is intended to be disposedafter one or several uses may include a one-time use battery as thepower source (1306), while devices that are intended to be sterilizedand reused more than several times may include the power source (1306)as a rechargeable battery, replaceable battery, or a connection via USBto a pre-existing source of power on or connected to the associatedsurgical instrument (e.g., the power source (1006)).

The integration module (1300) may be implemented in different ways, andmay be, for example, a single board computer or module having varyingform factor and capabilities suitable for a particular application. Forexample, an integration module for the control overlay (500) may need tobe small enough to be compartmentalized on the surface of the overlay;or may need to be curved to fit within the body. As another example, anintegration module for the suction instrument (1100) may need to bedesigned with a hole or channel on its surface so that the suction pathis not blocked, interrupted, or diverted. As yet another example, anintegration module for the control clip (1200) may need to be splitacross several components or boards that may be stacked within thecontrol module (1202). Other ways in which the features of theintegration module (1300) may be formed, packaged, or integrated withone or more of the examples disclosed herein exist and will be apparentto one of ordinary skill in the art based on the disclosure herein.

IV. Method for Input Pattern Configuration and Detection

As has been previously discussed with reference integral controls suchas those shown in at least FIGS. 3, 11-13, and 16-20, inputs received bythose devices and communicated to the IGS navigation system (100) may bereceived or interpreted as a variety of commands, from basic systemcommands (e.g., moving a mouse cursor or pressing an enter button orspace bar) to more complex software specific commands (e.g., setting andrecalling a pre-set perspective or viewpoint within an IGS navigationapplication). Such commands may either be provided by the integralcontrol to the IGS navigation system (100) in a form that can be useddirectly by the IGS navigation system (100); or may be provided in aform that can be interpreted or otherwise converted by the IGSnavigation system (100) prior to use. As an example, a rapid series ofinputs may be received via a control such as the proximity controlcluster (912), and the IGS navigation system (100) may have to parsethat series of inputs to determine if they are discrete inputs (e.g.,independent and unrelated movements of the mouse cursor) or if they area pattern associated with activating a more complex action (e.g.,recalling the view or perspective to a pre-set location andorientation).

FIG. 21 depicts a set of steps that may be performed by a configureddevice such as the IGS navigation system (100) to detect, identify, andreact to inputs from one or integral controls, such as the proximitycontrol (812), the proximity control cluster (912), the control overlay(500), or the navigation wheels (410, 430). Initially, pattern detectionmay be configured for a device (block 640), which includes configuringwhat types of patterns the device is able to receive via one or morecontrols. As an example, this can be thought of as creating a mappingtable having a single column, where each row of the column is a uniqueinput. In the case of the proximity control (812), this could include arow for a single tap, a row for a double tap, a row for a triple tap, arow for each of swiping across the proximity control (812) up, down,left, and right, a long press, a short press, and other unique inputs.Next, pattern recognition may be configured (block 642) for the device,which includes configuring what types of actions the IGS navigationsystem (100) performs when a detectable pattern is recognized. This canbe thought of as creating a second column in the earlier mapping tableand assigning a reaction or task with each unique and detectable input.The result is similar to a key-value pairing, where each unique input isa key, and each resulting action is a value associated with that.

With pattern detection and recognition configured, the IGS navigationsystem (100) may then receive (block 644) signals from one or moreintegral controls during a procedure in which it is being used. Thiscould include receiving signals via a physical connection or wirelessly,from the communication module (450), the control overlay (500), or theport (810, 910) as a user of one of those devices interacts with thedevice. As the signals are received (block 644), the IGS navigationsystem (100) will analyze them and attempt to detect (block 646) one ormore patterns that have been configured (block 640). This could include,for example, comparing the received (block 644) signals to a datastructure such as the earlier discussed mapping table to determine if apattern contained therein has been defined. Where a pattern is detected(block 646), the IGS navigation system (100) will determine (block 648)a reaction or task associated with that pattern (e.g., by checking thevalue for that key in the mapping table) and then execute (block 650)that reaction or task.

If no pattern is detected (block 646) within an individual set ofsignals, or if a pattern is detected (block 646) and after an associatedtask is executed (block 650), the IGS navigation system (100) willcontinue to receive (block 644) additional signals and detect (block646) patterns contained therein. Variations on the above method forinterpreting and acting upon configurable inputs exist and will beapparent to one skilled in the art in light of this disclosure.

V. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A medical device comprising: (a) a medical procedure feature, whereinthe medical procedure feature is configured to interact with ananatomical structure of a patient; (b) a handle body adapted to begripped by a user, wherein the medical procedure feature is distal tothe handle body; (c) a set of controls positioned on the handle body andconfigured to provide inputs to an input controller when the set ofcontrols are interacted with by the user; and (d) a communication modulethat is operable to communicate with an image guided surgery (IGS)navigation system; wherein the input controller is configured to receivea set of inputs from the set of controls and provide the set of inputsto the IGS navigation system; and wherein the set of inputs isconfigured to cause the IGS navigation system to modify the perspectiveof an IGS application running on the IGS navigation system.

Example 2

The medical device of Example 1 wherein the set of controls comprises afirst navigation wheel and a second navigation wheel, wherein the firstnavigation wheel is oriented perpendicularly to the second navigationwheel.

Example 3

The medical device of Example 2, wherein the set of inputs comprises ahorizontal movement received from a rotation of the first navigationwheel, and a vertical movement received from a rotation of the secondnavigation wheel, and wherein the IGS navigation system is configured tomove a cursor horizontally in response to the horizontal movement of thefirst navigation wheel and the IGS navigation system is configured tomove the cursor vertically in response to the vertical movement of thesecond navigation wheel.

Example 4

The medical device of any one or more of Examples 2 through 3, whereinthe set of controls further comprises a first button that is activatedby depressing the first navigation wheel, and a second button that isactivated by depressing the second navigation wheel.

Example 5

The medical device of Example 4, wherein the set of inputs comprises asingle input received from interaction with one of the set of controls,and a combined input received from simultaneous interaction two or moreof the set of controls.

Example 6

The medical device of Example 5, wherein the set of inputs is configuredto cause the IGS navigation system to move and rotate the perspective ofan IGS application with six degrees of freedom.

Example 7

The medical device of any one or more of Examples 1 through 6, whereinthe set of inputs comprises a navigation wheel, and wherein thenavigation wheel comprises a set of spokes, each spoke having a firstconductive face connected to an electrical supply with a first voltage,each spoke further having a second conductive face connected to anelectrical supply with a second voltage.

Example 8

The medical device of Example 7, wherein the navigation wheel furthercomprises a conductive switch positioned to contact the first conductiveface when the navigation wheel rotates in a first direction, wherein theconductive switch is further positioned to contact the second conductiveface when the navigation wheel rotates in a second direction, andwherein the input controller is configured to determine the directionand speed of rotation of the navigation wheel based upon a set ofvoltages contacting the conductive switch during rotation.

Example 9

The medical device of any one or more of Examples 7 through 8, whereinthe navigation wheel further comprises a shaft having a first conductiveportion that supplies the first voltage to the first conductive face,and a second conductive portion that supplies the second voltage to thesecond conductive face.

Example 10

The medical device of any one or more of Examples 8 through 9, whereinthe conductive switch comprises a flexible conductive pin.

Example 11

The medical device of any one or more of Examples 1 through 10, whereinthe set of controls comprises a navigation wheel, and wherein thenavigation wheel is adapted to be fully exposed to sterilant during asterilization procedure.

Example 12

The medical device of any one or more of Examples 1 through 11, wherein:the medical procedure feature is a guidewire; and the communicationdevice is a wireless transceiver.

Example 13

The medical device of any one or more of Examples 1 through 12, whereinthe medical procedure feature comprises a guide catheter and a dilationcatheter slidably received by the guide catheter.

Example 14

The medical device of any one or more of Examples 1 through 13, whereinthe handle body comprises a proximal end and a distal end, wherein theset of controls are positioned at the distal end, proximal to themedical procedure feature.

Example 15

The medical device of any one or more of Examples 1 through 14, whereinthe IGS navigation system includes a display screen configured toprovide different cross-sectional views of a patient's head, wherein theinput controller is configured to change cross-sectional views of apatient's head displayed via the display screen in response to inputsprovided via the set of controls positioned on the handle body.

Example 16

A control overlay comprising: a body portion; a communication modulethat is operable to communicate with an image guided surgery (IGS)navigation system; and a set of controls positioned on the body portionand configured to provide inputs to an input controller when the set ofcontrols are interacted with by a user; wherein: the input controller isconfigured to receive a set of inputs from the set of controls andprovide the set of inputs to the IGS navigation system; the set ofinputs is configured to cause the IGS navigation system to modify theperspective of an IGS application running on the IGS navigation system;and the body portion is adapted to fit against a handle body of amedical instrument.

Example 17

The control overlay of Example 16, wherein the set of controls comprisesa pointing stick and a set of buttons.

Example 18

The control overlay of any one or more of Examples 16 through 17,further comprising a first cutout and a second cutout positioned alongthe body portion so that, when the body portion is fit against thehandle body of the medical instrument, a set of inner finger-grips ofthe medical instrument pass through the cutouts.

Example 19

The control overlay of any one or more of Examples 16 through 18,wherein the control overlay is adapted to attach to the handle bodyusing one or more of: a friction fit; an adhesive; a mechanical catch;and a magnetic mount.

Example 20

A method for providing user input to an image guided surgery (IGS)navigation system comprising the steps: fitting a control overlay to amedical instrument; pairing the control overlay with an IGS navigationsystem; receiving, at an input controller of the control overlay, a setof user inputs via a set of controls positioned on the control overlay;providing the set of user inputs to the IGS navigation system; whereinthe set of user inputs are configured to cause the IGS navigation systemto modify the perspective of an IGS application running on the IGSnavigation system.

Example 21

The medical device of any one or more of Examples 1 through 15, whereinthe set of controls comprises a proximity control positioned within aportion of the handle body, wherein the proximity control is configuredto detect the presence of an object proximate to an outwardly facingportion of the proximity control, wherein the proximity control isfurther configured to provide inputs to the input controller based uponthe presence of the object.

Example 22

The medical device of any one or more of Examples 13 through 15, or 21,wherein the medical procedure feature comprises a suction cannula thatis operable for suctioning material through a channel, wherein theproximity control is positioned outside of the channel, wherein thecommunication module comprises a port configured to couple the medicaldevice with the IGS navigation system and provide the medical devicewith power and communication of data.

Example 23

The medical device of any one or more of Examples 13 through 15, or 21through 22, wherein the proximity control comprises a cover on theoutwardly facing portion, wherein the cover is configured to seal theproximity control and the portion of the handle body and preventcontaminants or liquids from entering, wherein the cover is furtherconfigured to allow the passage of light through the cover.

Example 24

The control overlay of Example 16, wherein the set of controls comprisesa proximity control, wherein the proximity control is configured todetect the presence of an object proximate to an outwardly facingportion of the proximity control, wherein the proximity control isfurther configured to provide inputs to the input controller based uponthe presence of the object.

Example 25

A medical device comprising: a medical procedure feature, wherein themedical procedure feature is configured to interact with an anatomicalstructure of a patient; a handle body adapted to be gripped by a user,wherein the medical procedure feature is distal to the handle body; anintegration module comprising a control interface and a processor; a setof controls positioned on the handle body and configured to provideinputs to the control interface when the set of controls are interactedwith by the user; and a communication device that is operable tocommunicate with an image guided surgery (IGS) navigation system;wherein the processor is configured to: receive a set of inputs via thecontrol interface, wherein the set of inputs describes a combination andpattern of user interactions with the set of controls, identify an inputbased on the set of inputs, and determine whether the input is a deviceinput or a navigation input, where the input is a device input, modifythe operation of the medical procedure feature, and where the input is anavigation input, provide the input to the IGS navigation system,wherein the input is configured to modify the operation of an IGSnavigation software being executed by the IGS navigation system.

Example 26

The medical device of Example 25, wherein the set of controls comprisesa control selected from the group consisting of: a navigation wheel, abutton, a proximity control, a knob, and a pointing stick.

Example 27

The medical device of any one or more of Examples 25 through 26, whereinthe medical procedure feature comprises a suction cannula that isoperable for suctioning material through a channel, wherein the set ofcontrols and the integration module are positioned outside of thechannel.

Example 28

The medical device of Example 27, wherein the set of controls comprises:a first button and a second button positioned on a top surface of thehandle body, and a third button positioned on a side surface of thehandle body.

Example 29

The medical device of any one or more of Examples 27 through 28, whereinthe integration module comprises the communication device, and whereinthe communication device is configured to wirelessly transmit the inputto the IGS navigation system.

Example 30

The medical device of any one or more of Examples 25 through 28, whereinthe medical procedure feature comprises a cutting head that is operableto rotate an inner cutting edge to cut or shave material trapped againstan outer cutting edge, wherein the integration module is within thehandle body.

Example 31

The medical device of Example 30, wherein the set of controls comprisesa first button and a second button positioned on a side surface of thehandle body.

Example 32

The medical device of any one or more of Examples 30 through 31, whereinthe communication device is configured to transmit the input to the IGSnavigation system via a connection configured to provide the medicaldevice with power from a power source.

Example 33

The medical device of any one or more of Examples 25 through 32, furthercomprising a position sensing coil configured to produce positionsignals based on the position of the position sensing coil within anelectromagnetic field, wherein the communication device comprises acoupling unit, and wherein the processor is further configured toprovide the input to the IGS navigation system via the coupling unit.

Example 34

The medical device of any one or more of Examples 25 through 33, whereinthe handle body is sealed to prevent exposure of the integration moduleto liquids during sterilization of the medical device.

Example 35

The medical device of any one or more of Examples 25 through 34, whereinthe medical procedure feature comprises a suction cannula that isoperable for suctioning material through a channel of the medical devicewhen an external vacuum source provides suction via the channel, andwherein the input is configured to cause the external vacuum source toprovide suction via the channel.

Example 36

The medical device of Example 35, wherein the suction cannula that isoperable for providing irrigation via the channel when an externalirrigation source provides irrigation via the channel, and wherein theinput is configured to cause the external irrigation source to provideirrigation via the channel.

Example 37

A control comprising: a control body shaped to fit on a portion of amedical device; an integration module comprising a control interface, aprocessor, and a communication device, wherein the communication deviceis operable to communicate with an image guided surgery (IGS) navigationsystem; and a set of controls positioned on the control body andconfigured to provide inputs to the control interface when the set ofcontrols are interacted with by a user; wherein the processor isconfigured to: receive a set of inputs via the control interface,wherein the set of inputs describes a combination and pattern of userinteractions with the set of controls, identify an input based on theset of inputs, and determine whether the input is a navigation input,where the input is a navigation input, provide the input to the IGSnavigation system, wherein the input is configured to modify theoperation of an IGS navigation software being executed by the IGSnavigation system.

Example 38

The control of Example 37, wherein the processor is further configuredto: determine whether the input is a device input; where the input is adevice input, provide the input to the IGS navigation system, whereinthe input is configured to modify the operation of a medical device inuse with the IGS navigation system.

Example 39

The control of any one or more of Examples 37 through 38, wherein thecontrol body comprises: a device saddle; a first clamp arm extendingfrom the device saddle; a second clamp arm extending from the devicesaddle opposite the first clamp arm; and a control module positioned onthe first clamp arm, wherein: the set of controls are positioned on thecontrol module, the integration module is positioned within the controlmodule, and the first clamp arm and the second clamp arm fit oppositesides of the portion of the medical device.

Example 40

The control of Example 39, wherein the device saddle is shaped to fit agrip portion of a dilation catheter slider when the first clamp arm andthe second clamp arm are fit on opposite sides of the dilation catheterslider.

Example 41

The control of Example 40, wherein the first clamp arm and the secondclamp arm are flexibly biased towards each other.

Example 42

The control of Example 41, wherein an interior side of each of the firstclamp arm and the second clamp arm comprise an attachment featureadapted to increase the force necessary to remove the control body fromthe dilation catheter slider.

Example 43

The control of any one or more of Examples 37 through 42, furthercomprising a disposable battery configured to provide power to thecontrol interface, the processor, and the communication device.

Example 44

A method for providing user input to an image guided surgery (IGS)navigation system comprising the steps: fitting a control clip on a gripportion of a dilation catheter slider, wherein the control clipcomprises a device saddle shaped to fit against the grip portion, and aset of clamp arms shaped to grip opposite sides of the dilation catheterslider; pairing a communication device of the control clip with an IGSnavigation system; receiving, at a control interface of the controlclip, a set of user inputs via a set of controls positioned on thecontrol clip, wherein the set of inputs describes a combination andpattern of user interactions with the set of controls; identifying aninput based on the set of inputs, and determining whether the input is anavigation input; where the input is a navigation input, providing theinput to the IGS navigation system; wherein the input is configured tomodify the operation of an IGS navigation software being executed by theIGS navigation system.

VI. Miscellaneous

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one skilled in the artwithout departing from the scope of the present invention. Several ofsuch potential modifications have been mentioned, and others will beapparent to those skilled in the art. For instance, the examples,versions, geometrics, materials, dimensions, ratios, steps, and the likediscussed above are illustrative and are not required. Accordingly, thescope of the present invention should be considered in terms of thefollowing claims and is understood not to be limited to the details ofstructure and operation shown and described in the specification anddrawings.

We claim:
 1. A medical device comprising: (a) a medical procedurefeature, wherein the medical procedure feature is configured to interactwith an anatomical structure of a patient; (b) a handle body adapted tobe gripped by a user, wherein the medical procedure feature is distal tothe handle body; (c) an integration module comprising a controlinterface and a processor; (d) a set of controls including at leastfirst and second controls positioned on the handle body, wherein thefirst and second controls are configured to provide a set of inputs tothe control interface when each of the first and second controls areinteracted with by the user; and (e) a communication device that isoperable to communicate with an image guided surgery (IGS) navigationsystem; wherein the processor is configured to: (i) receive the set ofinputs via the control interface, wherein the set of inputs describes acombination and pattern of user interactions with each of the first andsecond controls; (ii) identify an input based on the set of inputs, anddetermine whether the input is a device input or a navigation input;(iii) relay information regarding the operation of the medical procedurefeature where the input is a device input; and (iv) provide the input tothe IGS navigation system where the input is a navigation input; whereinthe input is configured to modify the operation of an IGS navigationsoftware being executed by the IGS navigation system.
 2. The medicaldevice of claim 1, wherein the first and second controls are selectedfrom the group consisting of: a navigation wheel; a button; a proximitycontrol; a knob; and a pointing stick.
 3. The medical device of claim 1,wherein the medical procedure feature comprises a suction cannula thatis operable for suctioning material through a channel, wherein the setof controls and the integration module are positioned outside of thechannel.
 4. The medical device of claim 3, wherein the integrationmodule comprises the communication device, and wherein the communicationdevice is configured to wirelessly transmit the input to the IGSnavigation system.
 5. The medical device of claim 1, wherein the medicalprocedure feature comprises a cutting head that is operable to rotate aninner cutting edge to cut or shave material trapped against an outercutting edge, wherein the integration module is within the handle body.6. The medical device of claim 5, wherein the first control comprises afirst button, wherein the second control comprises a second buttonpositioned on a side surface of the handle body.
 7. The medical deviceof claim 1, further comprising a navigation guidewire configured toproduce position signals based on the position of the navigationguidewire within an electromagnetic field, wherein the communicationdevice comprises a coupling unit, and wherein the processor is furtherconfigured to provide the input to the IGS navigation system via thecoupling unit.
 8. The medical device of claim 1, wherein the handle bodyis sealed to prevent exposure of the integration module to liquidsduring sterilization of the medical device.
 9. The medical device ofclaim 1, wherein the medical procedure feature comprises a suctioncannula that is operable for suctioning material through a channel ofthe medical device when an external vacuum source provides suction viathe channel, and wherein the input is configured to cause the externalvacuum source to provide suction via the channel.
 10. The medical deviceof claim 9, wherein the suction cannula is operable for providingirrigation to the anatomical structure via the channel when fluidlycoupled with an external irrigation source, and wherein the input isconfigured to cause the external irrigation source to provide irrigationvia the channel.
 11. The medical device of claim 1, wherein the firstand second controls include first and second proximity controlspositioned on the handle body that receive as input various motions ormovements of an object within a detectable distance above the first andsecond controls.
 12. The medical device of claim 10, further comprisinga control vent disposed on the handle body, wherein the control vent isconfigured to manually alter the amount of suction through the suctioncannula.
 13. A medical device comprising: (a) a medical procedurefeature configured to interact with an anatomical structure of apatient; (b) a handle body adapted to be gripped by a user, wherein themedical procedure feature is distal to the handle body; (c) anintegration module comprising a control interface and a processor; (d) aset of controls including a proximity sensor positioned on the handlebody, wherein the proximity sensor is configured to provide a set ofinputs to the control interface when the proximity sensor is interactedwith by the user, wherein the proximity sensor comprises: (i) an opticaltransmitter that is operable to project a light at a target, and (ii) anoptical receiver that is operable to receive the light as the lightreflects off the target; and (e) a communication device that is operableto communicate with an image guided surgery (IGS) navigation system;wherein the processor is configured to: (i) receive the set of inputsvia the control interface, wherein the set of inputs describes acombination and pattern of user interactions with the proximity sensor;(ii) identify an input based on the set of inputs, and determine whetherthe input is a device input or a navigation input; (iii) relayinformation regarding the operation of the medical procedure featurewhere the input is a device input; and (iv) provide the input to the IGSnavigation system where the input is a navigation input; wherein theinput is configured to modify the operation of an IGS navigationsoftware being executed by the IGS navigation system.
 14. The medicaldevice of claim 13, wherein the proximity sensor comprises a capacitivesensor.
 15. The medical device of claim 13, wherein the proximity sensorreceives the set of inputs as motions or movements of the target withina detectable distance from the proximity sensor that is positioned onthe handle body.
 16. The medical device of claim 13, wherein the medicalprocedure feature includes a suction cannula that is operable forsuctioning material through a channel of the medical device, wherein theinput is configured to modify the operation of an IGS navigationsoftware being executed by the IGS navigation system to alter an amountof suction provided to the channel of the medical device by an externalsuction source.
 17. A medical device comprising: (a) a medical procedurefeature, wherein the medical procedure feature is configured to interactwith an anatomical structure of a patient; (b) a handle body adapted tobe gripped by a user, wherein the medical procedure feature is distal tothe handle body; (c) an integration module comprising a controlinterface and a processor; (d) a set of controls including a proximitycontrol cluster positioned on the handle body, wherein the proximitycontrol cluster is configured to provide a set of inputs to theproximity control interface when the proximity control cluster senses amotion or movement of an object within a detectable distance above theproximity control cluster; and (e) a communication device that isoperable to communicate with an image guided surgery (IGS) navigationsystem; wherein the processor is configured to: (i) receive a set ofinputs via the control interface, wherein the set of inputs describes acombination and pattern of user interactions with the proximity controlcluster; (ii) identify an input based on the set of inputs, anddetermine whether the input is a device input or a navigation input;(iii) relay information regarding the operation of the medical procedurefeature where the input is a device input; and (iv) provide the input tothe IGS navigation system where the input is a navigation input; whereinthe input is configured to modify the operation of an IGS navigationsoftware being executed by the IGS navigation system.
 18. The medicaldevice of claim 17, wherein the proximity control cluster includesfirst, second, third, and fourth proximity sensors that are arranged ina diamond pattern.
 19. The medical device of claim 18, wherein actuationof the first, second, third, and fourth proximity sensors are configuredto cause the IGS navigation system to move a mouse cursor in apredetermined direction, or to navigate, scroll, or zoom an image or aview.
 20. The medical device of claim 17, wherein the set of inputsincludes a scrolling motion across the proximity control cluster tocause the view or perspective to scroll, rotate, or zoom, or a clockwiseor counter-clockwise rotational motion around the perimeter of theproximity control cluster to cause a view or a perspective to rotate orzoom.